OEM/ODM integral para dispositivos médicos domésticos
De la definición del producto al producto certificado con su marca: diseño, moldes, registro regulatorio, evidencia clínica, fabricación y logística.
Four services, one programme
- Research and regulatory: product preliminary research, CRO services, clinical trials, testing and certification.
- Design and engineering: appearance, structural, brand and packaging design; electronics, embedded and mobile software development; prototype and performance testing.
- Manufacturing: mould design and development, in-house injection moulding, assembly, packaging and inspection.
- Logistics and finance: medical-device-compliant warehousing, import/export customs handling, and supply-chain finance to improve your working capital turnover.
How a programme runs
- 1. Requirement review — target market, channel, price band and regulatory route.
- 2. Product definition — select a platform from the catalogue or scope a new one.
- 3. Industrialisation — tooling, packaging artwork, firmware and app configuration.
- 4. Verification — performance, safety and EMC testing with documented results.
- 5. Regulatory submission — FDA, EU MDR, NMPA or your national registration, supported by our technical file.
- 6. Production and delivery — ramp from pilot lots to volume, with export documentation.
Commercial terms
| Item | Detail |
|---|---|
| Lead time | 3-15 days for core components, supported by strategic chip stock |
| Order volume | Hundreds to hundreds of thousands of units |
| Customisation | Cuff, housing, display, language pack, app skin, packaging and instruction manual |
| Regulatory support | FDA, EU MDR CE, NMPA, plus CFS and FCC documentation |
| Tooling | Own mould shop — tooling cost and ownership agreed per project |
Intellectual property
We hold 23 patented technologies in infrared sensor temperature measurement and photoelectric physiological monitoring. Tooling and product IP ownership is agreed in writing at project start — we do not sell a customer-specific design to another customer.
What is the minimum order quantity?
Can you support registration in our country?
Do you do private label?
How do we start?
Red de fabricación
Red de producción «2+1» en tres regiones
Cuatro sitios, un mismo estándar de calidad: producción certificada GMP en Shenzhen, componentes clave localizados en Vietnam y una nueva planta en Zhongshan en construcción.
Línea de producción digital
Cada línea funciona con un tablero kanban digital
Cada línea de montaje se gestiona con un tablero kanban digital: el avance de los pedidos, la producción por hora, el tiempo de ciclo y los datos de calidad en línea se muestran en tiempo real junto a la línea. El material se solicita estación por estación, las anomalías activan alertas andon al instante y los mismos registros alimentan la trazabilidad de lote — así las marcas pueden auditar datos de línea en cualquier momento, no solo las unidades terminadas.
Diseño industrial y de envases, en casa
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Últimas noticias y ferias
Ferias, hitos de certificación y novedades de la empresa.
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